Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01207427 | Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain | PHASE2 | COMPLETED | 131 | — | — | Oct 14, 2010 | Jun 28, 2011 | Sep 25, 2018 | - | — |
An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). |
| ADL5945 0.1 mg | EXPERIMENTAL | During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. |
| ADL5945 0.25 mg | EXPERIMENTAL | During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| ADL5945 0.1 mg | DRUG | - |
| ADL5945 0.25 mg | DRUG | - |
Key Inclusion Criteria * be a man or woman aged 18 to 75 years, inclusive, at the time of screening * have a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kilograms per square meter (kg/m\^2) * be taking a stable daily dose of opioids of ≥30-milligrams (mg) morphine-equivalent tota...